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Cholangiocarcinoma News

Continuing Progress in Cholangiocarcinoma and Bilary Tract Cancers

March 2021, Vol 2, No 1
Milind M. Javle, MD
Professor
Department of Gastrointestinal Medical Oncology
Division of Cancer Medicine
The University of Texas
M.D. Anderson Cancer Center
Houston, TX
Chair
NCI Task Force: Hepatobiliary Cancers

Dear Colleagues,

It gives me great pleasure to introduce the March issue of CCA News. Once again, we have several recent developments in cholangiocarcinoma (CCA) clinical research, and these have been reviewed by leaders in the field.

At the CCA Summit held during the 2021 ASCO Gastrointestinal Cancers Symposium, Rachna T. Shroff, MD, MS, from the University of Arizona Cancer Center, has provided a detailed overview of the 15 clinical trials and research presented at the meeting that focused on developments in biliary tract cancers and CCA. A succinct summary of her presentation at the meeting is presented in this issue.

These 15 studies include the pivotal phase 2 clinical trial of infigratinib for the treatment of advanced, chemorefractory CCA associated with FGFR2 fusions and gene rearrangements. The results of this trial indicate a new therapeutic opportunity for patients with CCA. We hope that this promising agent receives FDA approval.

The updated results of the clinical trial ClarIDHy indicate an improved overall survival with the IDH1 inhibitor, ivosidenib (Tibsovo), compared with placebo, showing a beneficial effect on patients’ quality of life.

Other novel agents presented at the meeting included silmitasertib, an oral casein kinase 2 inhibitor; zanidatamab, a dual kinase HER2/neu inhibitor; neratinib (Nerlynx); and the novel arginase inhibitor, INCB001158.

This issue also includes several presentations from the 2020 CCA Summit. Abby Siegel, MD, MS, from Merck, provided an insightful and nuanced view of the role of immune checkpoint inhibitors in CCA and biliary tract cancers. Although the efficacy signal of immunotherapy has been somewhat muted, sequencing studies have identified “immunogenic clusters” that need prospective studies. She also noted that the role of chemotherapy as an adjunct to immunotherapy may be context-dependent, with higher responses seen in bladder cancer or lung cancer compared with biliary tract cancers. In the KEYNOTE-158 trial, which involved multiple solid tumors, including biliary tract cancers, a tumor mutational burden (TMB) of ≥10 was associated with a higher response rate than seen in those with low TMB. The median TMB in biliary tract cancers tends to be low.

Flavio Rocha, MD, of Virginia Mason Medical Center, has presented the rationale for the new American Joint Committee on Cancer 8th edition staging system for CCA and the implications for clinical practice.

Neoadjuvant and perioperative strategies are gathering momentum in the management of patients with CCA, as discussed by James Harding, MD, from Memorial Sloan Kettering Cancer Center.

Two recent retrospective studies, one by Hop S. Tran Cao, MD, FACS, from M.D. Anderson Cancer Center, and another from Amit Mahipal, MBBS, MPH, from the Mayo Clinic, have reviewed the National Cancer Database. They suggest that neoadjuvant therapy is being used increasingly for node-positive disease and may result in a survival advantage over upfront surgery.

We look forward to your feedback and contributions in the upcoming issues!

Sincerely,

Milind Javle, MD

Milind Javle, MD
Professor
Department of Gastrointestinal Medical Oncology
Division of Cancer Medicine
The University of Texas
M.D. Anderson Cancer Center
Houston, TX
Chair
NCI Task Force: Hepatobiliary Cancers

Related Items

Considering Toxicities Associated with Specific and Pan-FGFR Inhibitors
By Jesús Bañales, PhD; Antoine Hollebecque, MD; Milind M. Javle, MD; Angela Lamarca, MD, PhD, MSc
Videos
Drs Javle, Báñales, and Hollebecque describe their thoughts about the use of pan-FGFR inhibitors compared with those that primarily target FGFR2 and the potential of treating CCA with inhibitors of FGFR1, 3, and 4. Moreover, they consider the most common adverse events associated with inhibitors of FGFR2, of which the most difficult to manage are hyperphosphatemia, nail toxicity, eye toxicity, and fatigue. The importance of educating oncologists on how to treat these toxicities is key to maintaining dose intensity of FGFR inhibitors.
The Role of FGFR Inhibitors in Treating FGFR2 Fusion–Positive Cholangiocarcinoma
By Antoine Hollebecque, MD; Milind M. Javle, MD
Videos
Drs Javle and Hollebecque review the phase 2 clinical trial efficacy data of pemigatinib, infigratinib, and futibatinib as second-line therapy of FGFR2 fusion–positive cholangiocarcinoma, and explore use of these agents in the first-line and adjuvant settings.
Takeaways from the 2020 Cholangiocarcinoma Summit
By Milind M. Javle, MD
December 2020, Vol 1, No 3
In this last issue for the year, we are highlighting the proceedings of the Second Annual Cholangiocarcinoma (CCA) Summit, which was conducted on October 22-23, 2020. This summit attracted a wide, multidisciplinary audience and was very interactive, despite being a virtual event. An important focus for this meeting was the emergence of molecular targets in CCA and early successes seen with precision medicine in this disease. Many of the key presentations from the summit are included in the current issue and are highlighted below.
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By Ghassan K. Abou-Alfa, MD, MBA; Bruce Lin, MD; Farshid Dayyani, MD, PhD; Richard Kim, MD; Rachna T. Shroff, MD, MS; Melinda Bachini; Milind M. Javle, MD
December 2020, Special Issue: Managing CCA in the Setting of COVID-19
The first confirmed case in the United States of the 2019 novel coronavirus (COVID-19) was reported on January 21, 2020, and as of November 27, 2020, there were >63 million confirmed cases and >1.5 million deaths globally. Despite the global impact, certain populations have been identified as having a higher risk of developing severe COVID-19 infection, including patients with cancer. Various studies have shown that patients with cancer experience particularly poor outcomes after COVID-19 infection. As a result of the pandemic, care delivery has been disrupted to some degree based on the need for prioritization and limitations on resources. Therefore, healthcare providers and patients have been continually reassessing the balance between the benefits and risks of anticancer interventions in the context of the added risk of COVID-19 infection.
Important Advances in Cholangiocarcinoma Management
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While the COVID-19 pandemic rages throughout the world, patients, providers, and healthcare advocates are learning to survive in an alternative (virtual) world that is likely to change the face of medicine forever. Cholangiocarcinoma (CCA) is a complex disease that requires multidisciplinary care. Virtual clinic visits and online tumor boards and symposia represent just a few of the countless innovations introduced over the past year.
Welcome to the Inaugural Issue of CCA News
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It is my great pleasure to launch the inaugural issue of CCA News, an important new publication highlighting the latest research and development in cholangiocarcinoma (CCA). I am proud that we now have a focused publication on biliary tract cancers and am humbled to serve as the first editor-in-chief.
Hot Topics on Cholangiocarcinoma and Biliary Tract Cancer Presented at ASCO 2020
By Milind M. Javle, MD
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Several hot topics were presented at the recent ASCO 2020 annual meeting about cholangiocarcinoma (CCA), which I would briefly discuss here. First, it was very exciting to see 3 important studies regarding immunotherapy for CCA, which may represent a step forward in the development of CCA therapies.

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